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0.6 vs. 1.2 mg Atropine Together With Neostigmine 2.5 mg on Heart Rate in Patient Receiving Muscle Relaxant

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ClinicalTrials.gov Identifier: NCT02186132
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : July 10, 2014
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Brief Summary:

Balanced general anesthesia with neuromuscular blocking agents has been widely used for surgery.. At the end of surgery, neostigmine has been given for the reversal of neuromuscular blocking agents with several adverse effects such as bradycardia and profuse secretion. Atropine has been used to prevent those side effects of neostigmine. The routine dosages of the two drugs are 2.5 mg of neostigmine and 1.2 mg of atropine.

Tribuddharat S ey al. (1) has demonstrated that after giving 0.9 mg atropine together with 2.5 mg of neostigmine the mean heart rate during 1-8 minutes after the administration was increase 2-26 beats/min (bpm). At 9 and 10 minutes after administration of the drugs, the mean heart rate were decrease 0.9 and 1.6 bpm In the control group which receiving 1.2 mg of atropine, the mean heart rate during 1-10 minutes after administration was increase 4-32 bpm. However this study did not report the incidence of bradycardia and blood pressure. The mean heart rate prior to atropine and neostigmine was 74.43 + 11.82 bpm.(1)

Salem MG et al. (2) has demonstrated that after receiving 1.2 mg of atropine and 5 mg of neostigmine the mean heart rate during 2-110 minutes was decrease 5-29 bpm with the lowest heart rate at 40 minutes after administration. This study also did not report the blood pressure.

The baseline heart rate (HR) before administration of the reversal was associated with the following heart rate. Heinonen J et al. (3) has demonstrated that 80% of the patients after receiving 0.015 mg/kg of atropine 3 minutes before 0.03 mg of neostigmine for the reversal of pancuronium experienced bradycardia (heart rate < 50 bpm) compared with none in patients receiving alcuronium. However, before administration of atropine and neostigmine, the mean heart rate of patients was significantly lower in the pancuronium group.

Either tachycardia or bradycardia with hypotension causes adverse affect to patient especially in specific group like patient with coronary artery disease or undergoing craniotomy.

The primary objective of our study is to demonstrate the effect on heart rate (HR) and blood pressure of 0.6 mg atropine and 2.5 mg neostigmine for the reversal of muscle relaxant compare to 1.2 mg atropine.


Condition or disease Intervention/treatment Phase
Bradycardia Neostigmine Adverse Reaction Adverse Reaction to Belladonna or Atropine Drug: Atropine 0.6 mg Drug: Atropine 1.2 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of 0.6 vs. 1.2 Milligram Atropine Together With Neostigmine 2.5 Milligram on Heart Rate in Patient Receiving Muscle Relaxant During General Anesthesia
Study Start Date : March 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Atropine 0.6 mg
Atropine 0.6 mg intravenous
Drug: Atropine 0.6 mg
Atropine 0.6 mg intravenous

Active Comparator: Atropine 1.2 mg intravenous
Atropine 1.2 mg intravenous
Drug: Atropine 1.2 mg
Atropine 1.2 mg intravenous




Primary Outcome Measures :
  1. heart rate [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. bradycardia [ Time Frame: 24 hours ]
    heart rate < 60 beats/min



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status 1-3
  • age = or > 18 years
  • patient receiving neuromuscular blocking agent

Exclusion Criteria:

  • baseline heart rate before administration of the study drugs < 65 bpm
  • history of allergy to the study drugs
  • patient receiving either of the following drugs include beta-blockers, calcium channel blocker, amiodarone or digoxin
  • history of complete heart block or second degree AV block.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186132


Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Sirilak Suksompong, MD Mahidol University

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02186132     History of Changes
Other Study ID Numbers: Si158/2012
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: July 2014
Keywords provided by Mahidol University:
heart rate
neostigmine
atropine
dosage
Additional relevant MeSH terms:
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Muscle Hypotonia
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Atropine
Neostigmine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinesterase Inhibitors
Enzyme Inhibitors
Parasympathomimetics